Vitamin D Augmentation of Tekturna (Aliskiren) in Hypertension

• Status: Unknown status
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

Summary

In this research study, the goal is to find out if a currently FDA-approved medication called Tekturna(Aliskiren) along with the addition of Vitamin D will lower blood pressure and improve heart function in the African American population. High blood pressure occurs earlier in life in African Americans, is more severe, and is associated with greater organ damage in relation to uncontrolled hypertension. Having low levels of Vitamin D is also very common in the African American population. Research has shown that there may be a link between low Vitamin D levels and the ability of high blood pressure medications to be fully effective.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wayne State University
• Collaborator: Novartis
• Treatments: Cholecalciferol; Ergocalciferols; Vitamin D; Vitamins

Criteria

Inclusion Criteria:

• Ages 30-74

• Systolic Blood Pressure 140-159 mm Hg and Diastolic Blood Pressure <100 OR Diastolic Blood Pressure 90-99mm Hg and Systolic Blood Pressure <160mm Hg

• Vitamin D deficiency: Serum 25-OH D >= 10 ng/ml (25 nmol/L) to < 20 ng/ml (50 nmol/L)

• Not using any antihypertensive medication(s) for the previous 3 months

Exclusion Criteria:

• Cancer(other than skin) known HIV or other medical condition that might limit life expectancy.

• Pregnant or nursing

• Know adverse reactions to DRI's

• Hepatitis or liver enzyme elevations > 1.5x normal

• Estimated glomerular filtration rate (EGFR) <50 ml/min/1.7m2

• Diabetes Mellitus

• Serum calcium > 10.5 mg/dl or history of hypercalcemia

• History of primary hyperparathyroidism

• Sarcoidosis or other granulomatous disease

• Taking > 500 mg/d of supplemental elemental calcium

• Taking any drugs that decrease absorption of vitamin D, ex:xenical

• Taking the drug cyclosporine

• Taking any antihypertensive medications in the previous 3 months

• History of kidney stones

• Planning to move > 50 miles in the next 9 months